Iris expander

ABSTRACT

In a first aspect of the subject invention, an iris expander is provided which includes a non-metallic, unitary, multi-segmented body which is expandable from a first state to a second state. The second state defines a larger footprint than the first state with the body being defined by a plurality of segments connected by living hinges. In a further aspect, an iris expander is provided which includes a multi-segmented body that is expandable from a first state to a larger-footprint second state. At least one aperture is formed in the body with a channel extending therefrom embedded in the body such that no portion thereof is exposed externally of the body. The channel is formed to accommodate a portion of an instrument for causing adjustment of the body with avoidance of direct contact of the instrument with the tissue of the iris.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/553,642, filed on Nov. 25, 2014, now allowed, which is a continuationof U.S. patent application Ser. No. 14/216,013, filed Mar. 17, 2014, nowU.S. Pat. No. 8,900,136, which claims priority to U.S. ProvisionalPatent Application No. 61/788,350, filed Mar. 15, 2013, the entirecontents of which are incorporated by reference herein.

BACKGROUND OF THE INVENTION

In order to minimize intra- and post-operative complications fromcataract extraction, a surgeon must have the best possible view ofintraocular tissue. There may be occasion when a small pupil isencountered, such as with pseudoexfoliation, posterior synechiae, use ofmiotics, or, uveitis.

If a pupil cannot be properly dilated for cataract extraction, there isrisk of: iris damage; incomplete aspiration of lens fragments andcortical material; damage to the posterior capsule; compromisedcapsulorhexis; loss of vitreous; and, dropped nucleus into the vitreouscavity.

A rise in the incidence of intraoperative floppy iris syndrome, or IFIS,has been noted. Cited results from a retrospective and prospective studyindicate that IFIS is encountered approximately 2% of the time. (Chang,D. F., Campbell J. R., “Intraoperative Floppy Iris Syndrome AssociatedWith Tamsulosin”, J. Cataract Refract. Surg. 2005; 31: 664-673). Most ofthe affected patients were found to be taking alpha 1 blockers, such astamsulosin (“Flomax”), to address benign prostatic hyperplasia. Alpha 1blockers may cause the iris dilator muscle to relax which makes pupildilation difficult.

Treatments prior to cataract extraction may include: a pharmacologicalapproach (NSAID's, preservative-free epinephrine, viscoelasticsubstances); mechanical manipulation (iris hooks/retractors, irisrings/dilators); and, iris surgery.

SUMMARY OF THE INVENTION

In a first aspect of the subject invention, an iris expander is providedwhich includes a non-metallic, unitary, multi-segmented body which isexpandable from a first state to a second state. The second statedefines a larger footprint than the first state with the body beingdefined by a plurality of segments connected by living hinges.Advantageously, with the subject invention, an iris expander may beintroduced in a low profile into a patient's eye and expandedtherewithin.

In a further aspect of the subject invention, an iris expander isprovided which includes a multi-segmented body that is expandable from afirst state to a second state. The second state defines a largerfootprint than the first state. At least one aperture is formed in thebody with a channel extending therefrom into a portion of the body withthe channel being embedded in the body such that no portion thereof isexposed externally of the body. The channel is formed to accommodate aportion of an instrument for causing adjustment of the body.Advantageously, with the subject invention, an iris expander may beprovided which may be adjusted by an instrument with avoidance of directcontact of the instrument with the tissue of the iris.

These and other features of the invention will be better understoodthrough a study of the following detailed description and accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an iris expander formed in accordance with the subjectinvention;

FIG. 2 shows the iris expander of FIG. 1 in a collapsed state;

FIG. 3 shows lobes useable with the subject invention;

FIGS. 4-6 are different views of a further iris expander formed inaccordance with the subject invention;

FIGS. 4A and 4B show different channel configurations useable with thesubject invention;

FIGS. 7-10 are different views of the iris expander of FIGS. 4-6 in acollapsed state;

FIGS. 11-13 are different views of a further iris expander formed inaccordance with the subject invention;

FIGS. 14-16 are different views of an iris expander similar to the irisexpander of FIGS. 11-13, but with frame-shaped lobes, in a collapsedstate;

FIGS. 17-19 are different views of a further iris expander formed inaccordance with the subject invention;

FIG. 20 shows the iris expander of FIGS. 17-19 in a collapsed state;and,

FIGS. 21-29 show various aspects of introducing and using an irisexpander formed in accordance with the subject invention.

DETAILED DESCRIPTION OF THE INVENTION

With reference to the Figures, an iris expander 10 is provided whichincludes a body 12 which is expandable from a first, collapsed state toa second, expanded state. The body 12 defines a larger footprint in thesecond state than in the first state. The expansion of the body 12allows for introduction of the iris expander 10 in a low profile stateand expansion in situ to expand an iris for an ophthalmic procedure,such as cataract extraction, and maintenance of that expanded state forthe duration of the procedure. After the procedure, the iris expander 10may be collapsed and removed.

In a first embodiment, the body 12 is multi-segmented and defined by aplurality of segments 14 connected by living hinges 16. With thisarrangement, the body 12 may be unitarily formed from non-metallicmaterials, such as polymeric materials, including, but not limited to,thermoplastics, elastomers and combinations thereof (e.g., copolymers ofthermoplastics/elastomers). The body 12 needs to be biocompatible andsterilizable. With the living hinges 16, the segments 14 are pivotablerelative to each other to permit the body 12 to be initially prepared inthe first state and then expanded to the second state. The living hinges16 provide pivot points and/or points of relief to facilitate resilientdeformation of the segments 14 when in the first state.

The living hinges 16 may be formed by thinned sections of the body 12 soas to define isthmuses between adjacent pairs of the segments 14. Theliving hinges 16 may be formed with initial forming (e.g., molding) ofthe body 12 so as to have thin flexible profiles and/or may be preparedby secondary manufacturing processes which allow for material removal(e.g., cutting) to define the thinned sections. The living hinges 16 aresufficiently flexible to permit reversible bending thereof in allowingfor angular rotation between two adjacent segments 14 about the joiningliving hinge 16.

Based on material selection and/or manufacturing technique for the body12, the body 12 may be adapted to be manually expandable (e.g., wherethe body 12 is formed of thermoplastic material (e.g., polypropylene))or to be self-expanding (e.g., where the body 12 is formed ofelastomeric or thermoplastic/elastomeric material (e.g., elastomericpolyurethane)). Where the body 12 is adapted to be manually expandable,the living hinges 16 need not be provided with any inherent memory orother bias for expansion of the body 12. Rather, as described below,manual force may be applied to the body 12 to achieve expansion. Theliving hinges 16 may be formed sufficiently rigid so as to remain in astate once urged into such position (e.g., remain in particular stateswith the body 12 in the second expanded state). This allows for the body12 to remain in a fixed state, such as the second state. Alternatively,where the body 12 is adapted to be self-expanding, the living hinges 16may include inherent memory so as to have an internal bias towards theexpanded, second state. Such memory may generate a force urging theliving hinges 16 towards the expanded state. This force will also act onthe segments 14. Sufficient force must be generated to not only causeexpansion of the body 12 but also overcome any resistive force of theiris in causing expansion thereof. Also, the inherent memory will imparta force to the living hinges 16 to maintain the living hinges 16 in theexpanded state. Preferably, the body 12 is initially formed in thesecond, expanded state where self-expanding is desired.

The body 12 is formed as a closed loop which is intended to engage themargin of the iris with at least portions of, preferably the entiretyof, its outer perimeter when in the expanded state. The body 12 can beof various shapes, including being elliptical (e.g., circular) orpolygonal (e.g., square). It is preferred that the segments 14 and theliving hinges 16 extend continuously about the length of the body 12without any interruptions so as to prevent any portion of the iris toextend through the body 12. It is further preferred that the body 12 begenerally planar with expansion from the first state to the second stateoccurring in a single expansion plane.

It is envisioned that irises of 5.0 mm or less may require expansion toallow for proper visual access into the eye during an ophthalmicprocedure. It is preferred that the footprint of the body 12 in thesecond state, as defined by outer side surface 29 of the body 12 (FIGS.4, 4A, 4B), define a diameter of at least 6 mm, more preferably at least7 mm.

With reference to the Figures, the segments 14 can be provided invarious lengths and shapes to provide desired first and second states ofthe body 12. The body 12 in the second state may have a generallycircular shape. In one variation, as shown in FIGS. 1 and 2, eight ofthe living hinges 16 may be provided which separates the body 12 intoeight of the segments 14, the segments 14 not being of equal length. Asshown in FIG. 2, primary segments 14A are each provided with an arcuateshape with the primary segments 14A being positioned to bow outwardlyfrom each other with the body 12 being in the first state. The remainingsegments 14 are configured to be located within the primary segments 14Awith the body 12 being in the first state. By way of non-limitingexample, four secondary segments 14B may be provided each of generallythe same length with one of the secondary segments 14B extending fromeach end of the primary segments 14A. Two tertiary segments 14C areprovided which each connect a pair of the secondary segments 14B. Withthis arrangement, as shown in FIG. 2, the secondary segments 14B and thetertiary segments 14C may be folded and maintained inside of the primarysegments 14A as shown. Lobes 18 formed on the body 12 should beconfigured to minimally inhibit, if not avoid altogether inhibiting,full collapsing of the body 12, particularly where the lobes 18 arelocated interiorly of at least some of the segments 14 with the body 12in first state. Thus, the lobes 18 formed on the tertiary segments 14Cshould be shaped to not inhibit full collapsing of the secondarysegments 14B inside of the primary segments 14A.

With reference to FIGS. 4-19, the body 12 may be formed with thesegments 14 being of equal lengths. FIGS. 4-10 show the body 12 havingeight of the living hinges 16 which separates the body 12 into eight ofthe segments 14. Alternatively, as shown in FIGS. 11-19, the body 12 maybe formed with four of the living hinges 16 separating the body 12 intofour of the segments 14.

The locations of the living hinges 16 and the lengths of the segments 14will affect the configuration of the body 12 in the first state. FIG. 2,discussed above, provides a first state which is expandable outwardlyalong two Cartesian axes (represented in FIG. 2 by “X” and “Y” arrows).FIGS. 7-10, 11-13 and 14-16 each show the body 12 in a first state whichis expandable outwardly along one Cartesian axis (represented in FIG. 7by “X” arrows). Here, the body 12 is collapsed about two of the livinghinges 16, which may be opposing, to define first and second ends 32,34. The lobes 18 are located exteriorly of all of the segments 14. Thebody 12 may foreshorten along the perpendicular Cartesian axis duringexpansion (represented in FIG. 7 by “Y” arrows) with this configuration.Living hinges 16 may be located at various mid-points between the firstand second ends 32, 34 depending on the lengths of the correspondingsegments 14. Where the segments 14 are of equal length, the livinghinges 16 will be located generally centrally between the first andsecond ends 32, 34. The living hinges 16 not located at the ends 32, 34may act as points of relief to facilitate resilient deformation of thesegments 14 in the first state. This allows for the segments 14 to havenatural at-rest arcuate shapes in the second state, yet be deformed togenerally straight shapes with the body 12 in the first state. Therelease of the segments 14 from the deformed straight states to theirnatural at-rest states may impart force of expansion to the body 12where self-expansion thereof is desired.

One or more of the lobes 18 may be provided on the body 12 for extendingover a portion of the iris during implantation and/or expansion of theiris expander 10. A plurality of the lobes 18 may be spaced about thebody 12 at equal intervals along a single edge of the body 12, such asfirst edge 24 of the body 12. The lobes 18 are positioned so that aportion of the iris is received adjacent thereto. This provides alocating function for the iris expander 10 relative to the iris andadditional stability in while expanding the body 12 and holding the body12 in the expanded state.

With reference to FIG. 3, the lobes 18 may be provided along both thefirst edge 24 and second edge 26 of the body 12. The lobes 18 on thefirst and second edges 24, 26 may be aligned about the perimeter of thebody 12 so as to form U-shaped pockets 28 directly between a pair of thelobes 18 located above and below. The pockets 28 may receive portions ofthe iris. Alternatively, with reference to FIGS. 4-6, the lobes 18 maybe spaced in equal intervals about each of the first edge 24 and thesecond edge 26 but out of phase between the first and second edges 24,26 so that the lobes 18 alternately protrude from the opposing edges 24,26 about the body 12. This arrangement provides upper and lowerstabilization without defining the pockets 28.

The lobes 18 may be formed solidly (FIG. 3) so as to be continuous orframe shaped (FIG. 14) with portions thereof being open. In addition,the lobes 18 may be located centrally (FIG. 4) or off-center (FIG. 17)on the segments 14. This allows for different positions of the lobes 18with the body 12 in the first state, as shown in comparing FIGS. 14-16and FIG. 20.

As shown in FIG. 3, one or more of the lobes 18 may include an aperture20 from which extends a channel 22. The channel 22 is formed toaccommodate a portion of an instrument for positioning the body 12and/or causing expansion of the body 12. The channel 22 may be blind ormay extend through the respective lobe 18 to a second aperture 30 so asto be exposed externally of the adjacent segment 14. If the lobes 18 areframe shaped, the instrument may be inserted into an open portionthereof.

In a second embodiment of the invention, and with reference to FIGS.4-19, the channel 22 is located to extend through one of the segments 14with the aperture 20 being exposed on the first edge 24 of the body 12along the corresponding segment 14. In this manner, the channel 22 isembedded in the segment 14 with no portion thereof exposed externally ofthe body 12, as shown schematically in FIGS. 4A and 4B. The channel 22is completely spaced inwardly from both inner side surface 27 and theouter side surface 29 of the body 12. This arrangement locates aninstrument received in the channel 22 out of axial alignment with theiris tissue. The channel 22 may be blind (FIG. 4A) or may extend to thesecond aperture 30 (FIG. 4B) which is exposed externally on the secondedge 26. With this arrangement, an instrument engaged in the channel 22is located inwardly of the margin of the iris. Thus, even with theinstrument extending through the second aperture 30, the instrument doesnot directly contact the iris. Preferably, the channel 22 extends alonga longitudinal axis which is transverse to the expansion plane. Further,a plurality of the channels 22 may be provided in the body 12, each witha corresponding aperture 20. The channel 22 may be evenly spaced aboutthe body 12. In addition, one of the lobes 18 may be located adjacent toeach of the channels 22. This allows for additional tissue stabilizationat potential locations of force application for expansion.

With respect to the second embodiment, the placement of the channel 22wholly within the body 12 may be utilized with various configurations ofthe body 12 as described above with respect to the first embodiment. Thebody 12 can be multi-segmented with a plurality of the segments 14.However, the living hinges 16 are not required for the second embodimentof the invention; various hinges, and other connections, between thesegments 14 may be utilized. In all other respects, the secondembodiment may be practiced in the same manner as the first embodiment.

With reference to FIGS. 21-29, various aspects of introducing and usingthe iris expander 10 is shown. Although a specific shape of the body 12is shown, it is to be understood that the body 12 can be formed with anyconfiguration discussed herein, including both the first and secondembodiments. With reference to FIG. 21, a corneal incision 36 isinitially made in a patient's eye to be treated. A typical cornealincision for cataract extraction may be utilized. The iris expander 10is introduced into the eye with the body 12 being in the first,collapsed state. With the iris expander 10 being manually expandable,forceps F or other instruments may be used to insert the iris expander10 through the corneal incision 36 and locate the iris expander 10within the iris I. Thereafter, the iris expander 10 is positioned sothat the iris margin is aligned with at least a portion of the lobes 18(FIG. 23). One or more instruments, such as hooks H (e.g., Sinskeyhooks), may be used to properly position the iris expander 10 (FIG. 24).Secondary incisions 38 in the cornea may be utilized as needed.Preferably, as shown in FIG. 25, the iris expander 10 is manuallyexpanded by applying force in generally opposing directions. As shownhere, certain segments 14, such as the primary segments 14A, may befirst extended outwardly. This partial expansion of the iris expander 10allows for partial expansion of the iris I. Thereafter, remainingportions of the body 12 may be expanded, such as shown in FIG. 26. Thiscontinues until full expansion of the iris expander 10 is achieved. Oncefully expanded (FIG. 28), an ophthalmic procedure may be conducted.After the procedure, the iris expander 10 is collapsed and removed usinga reverse procedure.

With self-expansion, the iris expander 10 may be maintained in the firststate by an introducer C inserted through the corneal incision 36 (FIG.29). The introducer C (e.g., a pusher plunger instrument) urges the irisexpander 10 therefrom to be located within the iris I. With release, theiris expander 10 expands to the second state. An instrument, such as oneor more hooks (e.g., Sinskey hooks), may be used to adjust the positionof the iris expander 10 as necessary. Once fully expanded (FIG. 28), anophthalmic procedure may be conducted. After the procedure, the irisexpander 10 is collapsed, e.g., by retraction into the introducer C.

What is claimed is:
 1. An iris expander comprising: a non-metallic,unitary, multi-segmented body which is expandable from a first state toa second state, said second state defining a larger footprint than saidfirst state, said body being a closed loop defined by a plurality ofsegments connected by living hinges, said body having an inwardly-facinginner surface and an outwardly-facing outer surface, wherein said livinghinges being formed by sections of said body between said segments whichare thinner between said inner surface and said outer surface thanadjacent portions of said body, wherein said body includes a first lobe,radially spaced from said living hinges, protruding from a first of saidsegments, said first lobe protruding outwardly from said outer surfaceof said first segment, and, wherein said body includes at least oneaperture, radially spaced from said living hinges, being formed in saidfirst segment with a channel extending therefrom into a portion of saidfirst segment, said channel being spaced inwardly of both said innersurface and said outer surface and located within a portion of saidfirst segment from which said first lobe protrudes.
 2. An iris expanderas in claim 1, wherein said body includes a plurality of lobes.
 3. Aniris expander as in claim 2, wherein said plurality of lobes alternatelyprotrude from opposing edges of said body.
 4. An iris expander as inclaim 2, wherein at least one pair of said plurality of lobes protrudesfrom said body to define a U-shaped pocket therebetween.
 5. An irisexpander as in claim 1, wherein said body includes elastomeric material.6. An iris expander as in claim 1, wherein said body includesthermoplastic material.
 7. An iris expander as in claim 1, wherein saidbody includes thermoplastic/elastomeric copolymer.
 8. An iris expanderas in claim 1, wherein said channel terminates at a second apertureformed in said first segment.
 9. An iris expander as in claim 1, whereina plurality of said apertures, each spaced from said living hinges, areprovided about said body.
 10. An iris expander as in claim 9, whereinsaid plurality of apertures are evenly spaced about said body.
 11. Aniris expander as in claim 1, wherein expansion of said body in expandingfrom said first state to said second state is generally in an expansionplane.
 12. An iris expander as in claim 11, wherein said channel extendsalong a longitudinal axis disposed transverse to said expansion plane.